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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN AGILITY TIBIA ANKLE IMPLANT

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DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN AGILITY TIBIA ANKLE IMPLANT Back to Search Results
Catalog Number UNK-EXTREM
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 06/23/2017
Event Type  Injury  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Complete product detail has not been received at this time. If further information is received a follow-up medwatch will be filed as appropriate.

 
Event Description

Patient was revised to address ankle infection.

 
Manufacturer Narrative

No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. The investigation could not draw any conclusions regarding the reported event. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameUNKNOWN AGILITY TIBIA
Type of DeviceANKLE IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6732096
MDR Text Key80674435
Report Number1818910-2017-21541
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK-EXTREM
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/21/2017 Patient Sequence Number: 1
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